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  • Evaluation of a novel antig...
    Porte, Lorena; Legarraga, Paulette; Vollrath, Valeska; Aguilera, Ximena; Munita, José M; Araos, Rafael; Pizarro, Gabriel; Vial, Pablo; Iruretagoyena, Mirentxu; Dittrich, Sabine; Weitzel, Thomas

    International journal of infectious diseases, 10/2020, Letnik: 99
    Journal Article

    •Due to the rapidly emerging SARS-CoV-2 pandemic and its tremendous public health challenges worldwide, there is a critical demand for rapid and easy to perform diagnostic assays.•The rapid antigen detection test evaluated here had a high diagnostic sensitivity and specificity in respiratory samples obtained from patients who mainly presented during the first week of COVID-19.•Rapid antigen detection has the potential to become an important tool for the early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods. In the context of the coronavirus disease 2019 (COVID-19) pandemic, the development and validation of rapid and easy-to-perform diagnostic methods are of high priority. This study was performed to evaluate a novel rapid antigen detection test (RDT) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in respiratory samples. The fluorescence immunochromatographic SARS-CoV-2 antigen test (Bioeasy Biotechnology Co., Shenzhen, China) was evaluated using universal transport medium with nasopharyngeal (NP) and oropharyngeal (OP) swabs from suspected COVID-19 cases. Diagnostic accuracy was determined in comparison to SARS-CoV-2 real-time (RT)-PCR. A total of 127 samples were included; 82 were RT-PCR-positive. The median patient age was 38 years, 53.5% were male, and 93.7% were from the first week after symptom onset. Overall sensitivity and specificity were 93.9% (95% confidence interval 86.5–97.4%) and 100% (95% confidence interval 92.1–100%), respectively, with a diagnostic accuracy of 96.1% and Kappa coefficient of 0.9. Sensitivity was significantly higher in samples with high viral loads. The RDT evaluated in this study showed a high sensitivity and specificity in samples mainly obtained during the first week of symptoms and with high viral loads, despite the use of a non-validated sample material. The assay has the potential to become an important tool for early diagnosis of SARS-CoV-2, particularly in situations with limited access to molecular methods.